Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk The ANRS 1265 Trial 英文参考文献.docVIP

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Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk The ANRS 1265 Trial 英文参考文献.doc

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Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk The ANRS 1265 Trial 英文参考文献

o Openaccess,freelyavailableonline PL S MEDICINE Randomized,ControlledInterventionTrial ofMaleCircumcisionforReductionofHIV InfectionRisk:TheANRS1265Trial Bertran Auvert1,2,3,4*,Dirk Taljaard5,Emmanuel Lagarde2,4,Joe¨lleSobngwi-Tambekou2,Re′mi Sitta2,4,Adrian Puren6 1Ho?pitalAmbroise-Pare′,AssitancePublique—Ho?pitauxdeParis,Boulogne,France,2INSERMU687,Saint-Maurice,France,3UniversityVersaillesSaint-Quentin,Versailles, France,4IFR69,Villejuif,France,5Progressus,Johannesburg,SouthAfrica,6NationalInstituteforCommunicableDisease,Johannesburg,SouthAfrica CompetingInterests:Theauthors havedeclaredthatnocompeting interestsexist. ABSTRACT Background AuthorContributions:BAdesigned thestudywithDT,EL,andAP.DT andAPwereresponsiblefor ObservationalstudiessuggestthatmalecircumcisionmayprovideprotectionagainstHIV-1 infection.Arandomized,controlledinterventiontrialwasconductedinageneralpopulationof SouthAfricatotestthishypothesis. operationalaspects,including laboratoryandfieldworkandin- countryadministrationofthestudy. BAmonitoredthestudywithinput fromELandwrotethepaperwith inputfromallauthors.BAanalyzed thedatawithRS,withinputsfrom JST.RSconductedtheinterim analysis. MethodsandFindings A total of 3,274 uncircumcised men, aged 18–24 y, were randomized to a control or an interventiongroupwithfollow-upvisitsatmonths3,12,and21.Malecircumcisionwasoffered totheinterventiongroupimmediatelyafterrandomizationandtothecontrolgroupattheend of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios(RR)ofHIVincidenceweredeterminedwith95%CI.ProtectionagainstHIVinfectionwas calculatedas1àRR.Thetrialwasstoppedattheinterimanalysis,andthemean(interquartile range) follow-up was 18.1 mo (13.0–21.0) when the data were analyzed. There were 20 HIV infections(incidencerate?0.85per100person-years)intheinterventiongroupand49(2.1per 100person-years)inthecontrolgroup,cor